BUDESONIDE ENEMA IN ACTIVE HEMORRHAGIC PROCTITIS - A CONTROLLED TRIALAGAINST HYDROCORTISONE FOAM ENEMA

Background: The aim was to compare budesonide enema, 2 mg/100 mL (Ento cort) and hydrocortisone acetate foam enema, 125 mg (Colifoam) in pati ents with active haemorrhagic proctitis. Methods: The trial was a cont rolled, randomized, investigator-blind study with two parallel groups. Endoscopy, histology and diary cards were used to assess the response to therapy. Safety was assessed by laboratory tests and adverse event recording. Results: Seventy-two patients were included, Investigation s were made before treatment and after 2 and 4 weeks. Both treatment g roups showed statistically significant improvement in endoscopic score s but significant differences between the groups were not found, In th e hydrocortisone group, plasma cortisol was significantly lowered afte r 4 weeks compared with budesonide. Bowel habits and quality of life v ariables did not differ between the treatments. The recorded adverse e vents were mild or moderate and may have been due to the proctitis. Co nclusions: These results suggest that budesonide enema is as effective as hydrocortisone foam enema, but without the potential for side-effe cts associated with suppression of plasma cortisol.